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NCT01367509 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function

A Phase 1 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT01367509 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 32 participants.

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The verdict

NCT01367509, a Phase 1 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.

Interventions

  • DRUG Methylnaltrexone (MNTX)

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2004-03
Est. Completion 2005-06
Phase Phase 1

Sponsor

Bausch Health Americas

168 total trials

What the Registry Record Tells You About NCT01367509

The ClinicalTrials.gov registry entry for NCT01367509 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Methylnaltrexone (MNTX) is the first listed.

NCT01367509 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01367509 about?

NCT01367509 is a clinical study titled "Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function". This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.

What is the current status of trial NCT01367509?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2004-03. Estimated completion is 2005-06.

What interventions are being tested in trial NCT01367509?

The interventions under investigation include: Methylnaltrexone (MNTX) (DRUG).

Who is sponsoring clinical trial NCT01367509?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.